Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT04035343

Conditions

Retinal Detachment

Metamorphopsia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Face down positioning

Supine positioning

Study Details

Brief summary:

Patients may experience metamorphopsia, or image distortion, after having vitrectomy to repair their rhegmatogenous retinal detachments especially those with a detached macula. Retinal displacement, as measured on autofluorescence photography, likely contributes to this distortion. It is thought that the retina slips inferiorly due to the residual subretinal fluid shifting as the patient transitions from the supine position intraoperatively to the sitting up position in the immediate postoperative period. By having the patient immediate position facedown or according to the retinal break, the risk of slippage is theoretically decreased.

Conditions

Retinal Detachment

Metamorphopsia

Study ID

NCT04035343

Start date

Aug 26, 2019

Status verified date

Apr, 2021

Completion date

Oct, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18
  • Diagnosis of primary rhegmatogenous retinal detachment needing pars plana vitrectomy with the detachment involving at least one of the temporal vascular arcades, which would allow retinal displacement to be detected on fundus autofluorescence photography

Exclusion Criteria:

  • Rhegmatogenous retinal detachment with an attached macula
  • Proliferative retinopathy grade C or worst
  • Prior vitrectomy for retinal detachment. Patients having had pneumatic retinopexy that failed to completely reattach the retina and therefore now needing vitrectomy are allowed into the study
  • History of preoperative binocular diplopia
  • Tamponade with silicone oil instead of gas
  • Inability to maintain post operation head positioning
  • Mental incapacity

Study Design

Enrollment

324 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Conventional face down positioning

Patients in third arm will be treated with the current standard of care, that is, they will be kept supine in the ophthalmic surgery chair after the completion of their surgery. They will then be taken to the recovery area where, once transferred to the care of the postoperative care unit staff, they will transition to face down positioning. They will maintain this positioning until their first day postoperative visit after which they will position according to the retinal breaks found during surgery.

experimental: Supine positioning

Patients in the second arm will be kept supine after the completion of their surgery. They will then be taken to the recovery area where, once transferred to the care of the postoperative care unit staff, they will maintain supine positioning. They will maintain this positioning until their first day postoperative visit after which they will position according to the retinal breaks found during surgery.

Interventions

Face down positioning

See description of the face down positioning group

Supine positioning

See description of the supine positioning group

Primary outcome measure

  • Retinal displacement [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Department of Ophthalmology, St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5C 2T2

Contacts

Rajeev Muni, MD Msc FRCSC

4168677411Rajeev.Muni@unityhealth.to

Phillip To

4168677411Philip.To@unityhealth.to

More Information

Sponsor

Unity Health Toronto

Last update posted

Apr 28, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2021-04-28.